(125 days)
No
The summary describes a digital imaging system and positioning software for patient verification, but there is no mention of AI or ML capabilities. The focus is on standard image acquisition and positioning adjustments.
No
This device is described as a diagnostic imaging device for patient positioning verification prior to radiation therapy treatments and a simulator for developing and verifying patient treatment protocols. It does not directly provide therapeutic treatment.
Yes
The device is explicitly described as a "diagnostic imaging device" used for "patient positioning verification".
No
The device description explicitly states it is a "RAD II KV Imaging device is mounted directly to the head of a Linear Accelerator or Cobalt Therapy device" and includes a "Digital Imager," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RAD II KV Imager and RAD II Simulator are described as diagnostic imaging devices used for patient positioning verification prior to radiation therapy treatments. They acquire images using X-rays of the patient's body.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The diagnostic function is based on imaging the patient's anatomy.
Therefore, the device falls under the category of medical imaging devices used for patient positioning and treatment planning in radiation therapy, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- A) The RAD II KV Imager device is used for verification of correct patient position in relation to the Radiation Therapy Machine Isocenter; and verification of the treatment fields in relation to anatomical and or fiducial landmarks prior to radiation therapy treatment.
- B) The RAD II Simulator device is intended for use in developing and verifying patient treatment positioning protocols for radiation therapy treatment of cancer.
-
- Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
-
- Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
-
- The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
-
- The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
-
- The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
-
- The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
Product codes
KPQ
Device Description
The RAD II KV Imaging device is mounted directly to the head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Therapist and or Oncologist, Radiation Oncologist, Clinical setting (Radiation Therapy)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040192, K003636, K032996, K946128, K834281
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left and the word "Acceletronics" on the right. The symbol is a combination of a circle with concentric rings and vertical bars. The word "Acceletronics" is written in a stylized font, and the letters have a textured appearance. The letters "SM" are written in a smaller font to the right of the word.
AUG 1 7 2010
510(k) Summarv May 10, 2010, revised 7/03/10
The following submission is provided following the format of 21CFR 807.92 for the RAD II Simulator & RAD II KV Imager.
-
- Submitter: ACCELETRONICS, INC. 602 Gordon Drive Exton, PA. 19341 USA Contact: Stephen E. Havnes Phone: 510/867-5336 Fax: 510/522-2635 Email: shaynes@acceletronics.com
-
- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
RAD II Simulator & RAD II KV Imager RAD II Simulator & RAD II KV Imager Therapy Attached Simulator/verification device System Simulator, Radiation Therapy 21CFR 892.5840 Class II Product Code: KPQ
3. Predicate Devices to claim substantial equivalence:
| A) Varian Medical Systems On-Board Imager | K040192 |
|---|---|
| B) Varian Medical Systems Portal Vision | K003636 |
| C) Elekta Synergy | K032996 |
| D) Oldelft Simulux-HP | K946128 |
| E) Haynes Radiation Ltd., Inc. RAD II Simulator | K834281 |
-
Description of the device: The RAD II KV Imaging device is mounted directly to the 4. head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.
Substantial Equivalence = The RAD II is substantially equivalent in name to predicated devices A-E as a "Simulator" or "On Board Imager" device. -
- Intended Use Statement:
A) The RAD II KV Imager device is used for verification of correct patient position in relation to the Radiation Therapy Machine Isocenter; and verification of the treatment fields in relation to anatomical and or fiducial landmarks prior to radiation therapy treatment.
- Intended Use Statement:
Substantial Equivalence: The RAD II KV Imager is substantially equivalent in usage as an "On Board Imager" when compared to the predicated devices A-C.
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Image /page/1/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left and the word "Acceletronics" on the right. The symbol is a combination of a target-like design and vertical bars. The word "Acceletronics" is written in a stylized font, and the letters are connected.
-
B) The RAD II Simulator device is intended for use in developing and verifying patient treatment positioning protocols for radiation therapy treatment of cancer.
Substantial Equivalence: The RAD II Simulator is substantially equivalent in usage as a "Radiation Therapy Simulator" when compared to the predicated devices D&E. -
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart on Exhibit C-4 provides a comparison of the technological characteristics and componentry to those of the predicate devices. The RAD II Simulator and the RAD II KV Imager are detailed in this chart Exhibit C-4 showing substantial equivalence of componentry to the predicate devices listed.
A) The predicate devices use:
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart on Exhibit C-4 provides a comparison of the technological characteristics and componentry to those of the predicate devices. The RAD II Simulator and the RAD II KV Imager are detailed in this chart Exhibit C-4 showing substantial equivalence of componentry to the predicate devices listed.
X-Ray Generator X-Ray Tube Collimator & Bearing Gantry Imaging Via X-ray Film Imaging Via Digital Imager Imaging Via Image intensifier Positioning Software Computer
RAD II Simulator and KV Imager Use:
X-Ray Generator X-ray Tube Collimator & Bearing Mounted to a Gantry Imaging Via X-ray Film Imaging Via Digital Imager lmaging via X-ray film Positioning Software Computer
- . The RAD II Simulator & RAD II KV Imager are substantially equivalent to the predicate RAD II Simulator device in almost all of its predicate capabilities. The differences exist in the RAD II KV Imager which has no delineator, but has advanced digital imaging,
- The RAD II Simulator & RAD II KV Imager are substantially equivalent to the . Oldelft Standalone Simulator in their ability to create relevant Patient positioning lmages for Radiation Therapy Treatment protocols, while using the Therapy gantry they are mounted to, and the Therapy couch, which is part of the Therapy System assembly.
- . The RAD II KV Imager is substantially equivalent to the predicate Varian On-Board lmager as a Therapy attached diagnostic device using digital imaging and Patient positioning software for required adjustments and verification for Radiation Therapy Treatment Protocols.
- The RAD II KV Imager is substantially equivalent to the predicate Portal Vision . Devices as a Therapy attached digital imaging Device using Digital Imaging and patient positioning software for required adjustments and verification for Radiation Therapy Treatment Protocols.
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Image /page/2/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left, resembling a target or radar screen, followed by the word "Acceletronics" in a stylized font. The letters of the word have a textured or patterned fill, and there is a small "SM" symbol in the lower right corner of the word.
| Exhibit C-4
RAD II Make, Model &
Operational Prd. | X-Ray Tube
Model & Make | X-Ray
Generator
Model & Make | Tube Mount
Model & Make | X-Ray Film
Model & Make | Film Cassette
Model & Make | Imager Model
& Make | Cassette &
Imager Mount
Model & Make | Patient
Positioning
software | Imager Comp.
Model & Make | Application
Comp. Model &
Make | 510K
Number |
|-----------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------|------------------------------|-------------------------------------------------|----------------|
| HRL RAD II
MODEL
Phantom-HF
2003-Present | Phantom Hd.,
Superior by
Dynarad & Del
Global 50-
100kVp | Phantom
Generator
Dynarad & Dell
Global, 12.5mA
fixed | Variable
Design by HRL
for Clinac &
Cobalt | Kodak
T-Mat-H. | Kodak Lannex
Regular & Fast | None | Variable
Design by HRL
for Clinac &
Cobalt | None | None | None | K834283 |
| HRL RADII Rad
Only MODEL 2001-
HF 1994-1999 | Rad-74, Eureka
50-125kVp | Futurus 2001
Generator by
Innerscan 50-
500mA | Variable
Design by HRL
for Clinac &
Cobalt | Kodak
T-Mat-H | Kodak Lannex
Regular | None | Variable
Design by HRL
for Clinac &
Cobalt | None | None | None | K834281 |
| HRL RAD II
Rad Only MODEL
2001-HF 1999-
Present | Rad-74, Varian
50-125kVp | SHF-320
Generator by
SEDECAL
25-300mA | Variable
Design by HRL
for Clinac &
Cobalt | Kodak
T-Mat-H | Kodak Lannex
Regular | None | Variable
Design by HRL
for Clinac &
Cobalt | None | None | None | K834281 |
| Single
Headed RAD
II KV Imager
MODEL 2001-HF
2009-Present | Qty. 1
Rad-60, Varian
50-150kVp | (1) SHF-320
Generator by
SEDECAL
25-300mA | HRL Shut Down in 2006, purchased bu Acceletronics in 2007. RAD II KV Imager product developed from 2008-2009 | | | QTY.1
NAOMI Imager
by RF
SYSTEMS
LAB | Fixed or
Retractable
Arm Design by
Acceletronics
for
Accelerators | Theraview
Software by
Cablon | Mini Computer
by Cablon | DELL PC
Loaded with
Theraview
software | K101038 |
| Dual Headed
RAD II KV
Imager MODEL
2001-HF 2009-
Present | Qty. 2
Rad-60, Varian
50-150kVp | (2) SHF-320
Generator by
SEDECAL
25-300mA | Retractable
Design by
Acceletronics
for
Accelerators | None | None | QTY.2
NAOMI Imager
by RF
SYSTEMS
LAB | Retractable
Arm Design by
Acceletronics
for
Accelerators | Theraview
Software by
Cablon | Mini Computer
by Cablon | DELL PC
Loaded with
Theraview
software | K101038 |
| Varian O.B.I.
2004-Present | Qty. 1
Rad-60, Varian
50-150kVp | (1) CPI Indico
100 Generator
by CPI 25-
300mA | Retractable
Head Design
by Varian
mounts to | None | None | Varian 4030
Amorph
Silicone
Imaging Panel | Retractable
Arm Design by
Varian mounts
to middle of
RetractablE | Proprietary
Software | Unknown? | PC at
Therapist
Console Area | K040192 |
| Elekta Synergy
Imager 2003
to present | Qty. 1 Rotating
Anode Tube 50
125kVp | (1) Generator
make/model
unknown | Retractable Head
Design mounts to
mid-gantry of
Clinac | None | None | Amorph
Silicone
Imaging Panel | Arm Design by
Elekta mounts
to middle of
RetractablE | Proprietary
Software | Unknown? | PC at
Therapist
Console Area | K032996 |
| Varian Portal
Vision 2004-
Present | | | | None | None | Varian 4030
Amorph
Silicone
Imaging Panel | Retractable
Arm Design by
Varian mounts
to Ctwt, Ass. | Proprietarg
Software | Unknown? | PC at
Therapist
Console Area | K003636 |
| Theraview | | | | None | None | CCD Camera
Imaging Panel | Theraview Rot. Arm
Darian mounts to
Gantry Chut. Arry. | Proprietary
Software | Unknown? | PC at
Therapist
Console Area | K960510 |
| Oldelft Simulux-HP | Qty. 1 R/F
Rotating
Anode Tube 50
150kVp | (1) R/F
X-Ray
Generator
25-500mA | Standalone
Gantry
Simulates an
Accelerator | None | None | Glass Image
Intensifier -
Variable sizes | Variable imager
Arm Design by
Oldelft mounts
to lower Gantry | Proprietary
Software | Unknown? | PC at
Therapist
Console Area | K945128 |
| RAD II
Simulator | Qty. 1 Fixed
Anode Tube 50
125kVp | (1) Generator
make by Porta
Ray/Dynarad | Typically fixed
Adapter mounts
to Head of
Accelerator | None | Kodak
Lannex Fast
Cassettes | | Variable
Design by HRL
for Clinac &
Cobalt | | | | K834281 |
・
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight or flowing lines, stacked vertically.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Stephen Haynes Project Design & Engineering Acceletronics Digital Imaging, LLC 602 Gordon Drive EXTON PA 19341
AUG 1 7 2010
Re: K101038
Trade/Device Name: Rad II KV Imager & RAD II Simulator Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulator system Regulatory Class: II Product Code: KPQ . Dated: July 29, 2010 Received: July 30, 2010
Dear Mr. Haynes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device . Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol to the left of the company name. The symbol is made up of concentric arcs intersected by vertical and horizontal lines, resembling a target or radar screen. The text "Acceletronics" is written in a stylized font to the right of the symbol, with the letters slightly slanted and connected.
Indications for Use Revised 7/03/10
510(k) Number (if known): K101038
Device Name: Rad II KV Imager & RAD II Simulator
Indications for use:
-
- Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
-
- Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
-
- The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
-
- The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
-
- The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
-
- The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
Prescription Use YES AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OIVD
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101038
Page 4.1
Acceletronics Digital Imaging, LLC. · 602 Gordon Drive · Exton, PA 19341 Toll Free 800-543-5144 · Service Dispatch 800-626-8704 · Fax 610-524-3304 · www.acceletronics.com